CTIS was established by pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014) and will completely replace the previous system for clinical trials EudraCT (European Union Drug Regulating Authorities Clinical Trials Database) after 30th January 2025. CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
CTIS is guaranteed by European Medicines
agency (EMA) and works in a secured workspace.
The important milestones for clinical trials:
CT starts after
30th January 2023 – the submission must be completed through CTIS
CT ends before
30th January 2025 – CT is maintained in EudraCT or national
systems
CT is expected
to continue after 30th January 2025 – transition from the EudraCT or
national systems to the CTIS is necessary.
CTIS podporuje interakce mezi sponzory klinických studií (výzkumníky nebo společnostmi, které provádějí klinickou studii a shromažďují a analyzují data) a regulačními orgány v členských státech EU...
